WuXi Biologics, a global contract research, development and manufacturing organization (CRDMO), has launched PatroLab, a next-generation digital twin platform aimed at reshaping bioprocess development and biologics manufacturing.

PatroLab integrates real-time process monitoring with Raman-based Process Analytical Technology (PAT), predictive in-silico modelling, and machine learning to deliver smarter analytics, proactive control, and faster decision-making. The platform is designed to enhance process performance, reduce operational risk, shorten development timelines, and ensure consistent, high-quality manufacturing outcomes, helping clients accelerate time-to-market and secure reliable commercial supply.

Commenting on the launch, Dr Chris Chen, chief executive officer of WuXi Biologics, said the platform represents a major step in building a predictable and accelerated path for biologics development. He noted that by unifying real-time analytics, predictive modelling, and automated control within a single digital ecosystem, PatroLab enables partners to improve efficiency and quality while accelerating innovation.

At the core of PatroLab is WuXi Biologics’ advanced Raman PAT system, which enables real-time, non-invasive monitoring of more than 40 critical process and product quality attributes. This marks a shift away from traditional off-line testing toward continuous, data-rich process oversight. The system increases data density per batch by nearly 1,000 times compared with conventional approaches, allowing more effective application of Quality by Design (QbD) principles.

The Raman PAT capability also supports rapid chemical characterization of complex raw materials, including cell culture media and buffers, detecting subtle molecular-level variations at the point of use. This allows early intervention to reduce batch variability and safeguard product consistency throughout manufacturing runs.

PatroLab further combines data-driven and mechanistic modelling with digital twin technology to create virtual replicas of bioprocesses. These models enable predictive decision-making, “what-if” scenario analysis, and refined control strategies. The platform supports early risk identification, root cause analysis during technology transfer and scale-up, and detection of potential process limitations such as nutrient metabolism bottlenecks or cell state shifts.

By aligning end-to-end monitoring and control with critical quality attributes, PatroLab helps reduce process deviations and batch rejection rates while improving batch-to-batch consistency. In line with regulatory guidance from authorities such as the FDA and EMA, the platform supports real-time release testing, complementing in-process quality controls and shortening manufacturing turnaround and release cycles.

Automated, model-predictive control replaces manual interventions, reducing scale-up risks and variability caused by operational inconsistencies. The result is greater efficiency, reliability, and robustness across biomanufacturing operations.

Embedded within WuXi Biologics’ broader digital ecosystem, PatroLab provides access to a centralized knowledge management infrastructure that breaks down data silos and enables real-time collaboration across teams. Its visualization and alerting tools support trend analysis, out-of-trend detection, and rapid root cause identification, strengthening manufacturing control across development and commercial production.

WuXi Biologics offers end-to-end CRDMO solutions spanning discovery, development, and commercial manufacturing of biologics, supporting partners worldwide in bringing therapies from concept to market.